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| Name | Class |
|---|---|
| NHS Blood and Transplant | OTHER_GOV |
| IPSOS | INDUSTRY |
| University of Nottingham | OTHER |
| Nottingham University Hospitals NHS Trust |
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DESIGN Observational epidemiological study
AIMS - To determine:
The aim of this proposal is to assess at a population level; 1) the proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the sociodemographic, disease, and treatment characteristics that influence antibody status; 2) if the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals.
The investigators aim to target patient groups least likely to mount an immune response to vaccination; a) solid organ transplant recipients; b) patients with a rare autoimmune disease c) patients with haematological malignancies, specifically lymphoid malignancies. The investigators will use comprehensive registries to identify and recruit patients from these groups, and utilise the existing linkages these registries already have to obtain COVID-19 outcome information.
The investigators hypothesise that a sizeable proportion of immunosuppressed people will have no detectable SARS-CoV-2 antibodies following a three vaccine doses, and that this cohort is particularly susceptible to SARS-CoV-2 infection and death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid organ transplant patients | Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine |
| |
| Rare autoimmune diseases | Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine |
| |
| Blood cancer | Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-administered lateral flow assays | Diagnostic Test | The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | 1. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented. | 21 - 90 days post 3rd vaccine |
| The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | 1. The proportion of participants with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented. | 21 - 90 days post 4th vaccine |
| The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period After 3rd or 4th Vaccine | The incidence of participants having at least one RT-qPCR proven infection in the 6-month follow-up will be presented for those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine. | 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies. |
| The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19 | The incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine | 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies. |
| Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Rates of those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine will be presented for different clinical characteristics and sociodemographic factors. | Antibodies at 21 - 90 days after 3rd or 4th vaccine |
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Inclusion Criteria:
Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Willicombe, MBBS, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Blood and Transplant | Bristol | United Kingdom | ||||
| Imperial College |
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| Label | URL |
|---|---|
| Published results | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Solid Organ Transplant Patients | Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2022 |
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| OTHER |
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|
| London |
| United Kingdom |
| Ipsos Mori | London | United Kingdom |
| National Disease Registration Service | London | United Kingdom |
| FG001 | Rare Autoimmune Diseases | Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
| FG002 | Blood Cancer | Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Solid Organ Transplant Patients | Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
| BG001 | Rare Autoimmune Diseases | Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
| BG002 | Blood Cancer-Lymphoid Malignancy | Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Overall age is not shown because we don't have a combined dataset for the whole cohort, so this can't be reported. Those with age not reported aren't included in any of the modelling. | Median | Inter-Quartile Range | years |
| |||||||||
| Sex: Female, Male | 16 participants did not report their gender. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total number of vaccines at time of test | Self-reported data on whether 3, 4 or 5+ vaccines at time of test | Rows added for 3, 4, 5+ vaccines at time of test | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | 1. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented. | Patients who have received 3 vaccines | Posted | Count of Participants | Participants | 21 - 90 days post 3rd vaccine |
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| Primary | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | 1. The proportion of participants with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented. | Patients who have received 4 vaccines | Posted | Count of Participants | Participants | 21 - 90 days post 4th vaccine |
| ||||||||||||||||||||||||||||||||||||
| Primary | The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period After 3rd or 4th Vaccine | The incidence of participants having at least one RT-qPCR proven infection in the 6-month follow-up will be presented for those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine. | Not Posted | Dec 2024 | 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies. | Participants | ||||||||||||||||||||||||||||||||||||||
| Primary | The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19 | The incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine | Not Posted | Dec 2024 | 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies. | Participants | ||||||||||||||||||||||||||||||||||||||
| Primary | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Rates of those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine will be presented for different clinical characteristics and sociodemographic factors. | After 3rd or 4th vaccine | Posted | Number | participants who received vaccines | Antibodies at 21 - 90 days after 3rd or 4th vaccine |
|
6 months
There were no adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solid Organ Transplant Patients | Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. | 0 | 9,927 | 0 | 9,927 | 0 | 9,927 |
| EG001 | Rare Autoimmune Diseases | Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. | 0 | 6,516 | 0 | 6,516 | 0 | 6,516 |
| EG002 | Blood Cancer | Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. | 0 | 6,593 | 0 | 6,593 | 0 | 6,593 |
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1.Participation required self-engagement 2. We used a non-quantitative test without distinguishing between absent & very low anti-SARS-CoV-2 IgG antibody concentrations nor antigen-specific T-cell responses 3.Covariates selected for the analysis were based on data captured via the research questionnaire that were clinically appropriate 4.Data processing approvals meant a single intracohort comparison analysis wasn't possible,but similar methodology & analysis was applied to the different cohorts
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gillian Powter Trial Manager | NHS Blood and Transplant | 44 7590 353091 | gillian.powter@nhsbt.nhs.uk |
| Oct 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D000086382 | COVID-19 |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Asian |
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| Black |
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| Other |
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| Not reported |
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| 4 vaccines |
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| 5+ vaccines |
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Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. Self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
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| Blood Cancer |
Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. self-administered lateral flow assays: The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%. |
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